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Carilex VT • 100/VT • 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT · 100/VT · 200 suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial-thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Carilex VT-100 and VT-200 devices:

Acceptance Criteria and Study for Carilex VT-100 and VT-200 (K173407)

Based on the provided FDA 510(k) summary, the Carilex VT-100 and VT-200 are powered suction pumps for negative pressure wound therapy. The substantial equivalence was primarily determined through non-clinical testing and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical tests (bench tests). It does not specify a "test set" in the context of patient data or clinical samples. The testing involved multiple devices (VT-100 and VT-200 models) in a laboratory setting. No information on the number of individual devices tested or their origin (provenance) is provided beyond the company being based in Taoyuan City, Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This was a non-clinical, bench testing study. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench tests would be the established performance specifications of the predicate device and relevant international standards.

4. Adjudication Method for the Test Set:

Not applicable. As this was non-clinical bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. Pass/fail criteria were based on predetermined engineering specifications and conformity to standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A MRMC study was not conducted as this was a non-clinical evaluation to demonstrate substantial equivalence to a predicate device, focusing on engineering and performance criteria rather than human reader interpretation of medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The VT-100 and VT-200 are physical powered suction pumps, not AI algorithms. Their performance is tested directly, not as an algorithm's output.

7. Type of Ground Truth Used:

The "ground truth" for this substantial equivalence determination was based on:

• Predicate Device Specifications: The performance characteristics (suction pressure, fluid removal rate, etc.) and safety profile of the legally marketed predicate device (VOLTERA Powered Suction Pump, S1001-3 Series, K112853).
• International Standards: Conformity to recognized standards such as AAMI/ANSI ES60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
• Engineering Specifications: Pre-determined performance specifications for the VT-100 and VT-200 devices themselves.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" in the context of this device and study type, as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set.

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Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers, and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.

This document describes the FDA's 510(k) summary for the Carilex VT.One/VT.One 60days powered suction pump. The device is a negative pressure wound therapy (NPWT) system.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The pumps met all pre-determined acceptance criteria and passed the tests." However, it does not provide a specific table of acceptance criteria or detailed reported device performance values for the non-clinical tests beyond confirming they passed. It only lists the tests performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set in the non-clinical performance/comparison testing. It only states that "Performance/Comparison Testing of VT.One 60days with the predicate" was conducted. This implies a comparison between the proposed device and the predicate. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given it's non-clinical testing of a medical device, it would have been conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This question is not applicable. The study described is non-clinical performance and safety testing of a medical device against established standards and a predicate device. It does not involve establishing ground truth from expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This question is not applicable as the study involved non-clinical performance testing against technical standards and a predicate, not human adjudication of medical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not performed."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The device is a powered suction pump, not an AI algorithm. Its performance is mechanical and electrical, not algorithmic. The term "standalone" in this context typically refers to the performance of an AI model without human intervention.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established international standards (IEC60601-1, IEC60601-1-2) for medical electrical equipment safety and essential performance, and comparability to the predicate device's performance specifications. This is a technical, rather than medical, ground truth.

8. The Sample Size for the Training Set

This question is not applicable. The device is a mechanical/electrical pump, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above (not an AI/ML algorithm).

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